Ectopic Bone Formation uye Medtronic Controversy

Ectopic inoreva chinhu kana mhuka dzomunhu dzinoita kana dziripo uko dzisiri dzaro. Ectopic bone yakarongwa ndiko kuiswa pasi kwetsva bone nyaya (kuburikidza nehutano hunonzi ossification) munzvimbo, zvakare, apo iyo nyaya haisi yake. Izvi zvinoshandiswa nemasero anonzi osteoblasts.

Izwi rokuti ectopic rinobva kune vaGiriki, uye rinoreva "kure kubva kune imwe nzvimbo." Zvinyorwa zvaro, izvo zvinoreva "orthotopic" bone - zvakare rakabva muchiGiriki - rinoreva pfupa rinoumbwa munzvimbo yayo yakarurama, nzvimbo inonzi Scott, et.

al., munyaya yavo ine musoro unoti "Brief Review of Models Ectopic Bone Formation." Nyaya yacho yakabudiswa mumagazini yaMarch 2012, Stem Cells Development.

Ectopic bone formation inogona kuvapo pakuberekwa, inokonzerwa neve genetics kana kuti inomuka sechinhu chinokonzerwa nezvimwe zvirwere zvakadai separaplegia uye / kana kuora mwoyo kukuvadza (kungoti vashomanana chete.) Scott, et. al. vanoti ectopic bone mazano inofungidzirwa kuti inokonzerwa nokuputika kwemukati kunoteverwa nekuungana kwemafupa emasenjini emasero. Maererano neBoston Children's Hospital's web site, anecgenitor cell inenge yakafanana nesero chetemiti kunze kwekuti inenge isina kukwana maererano nemhando dzemasero iyo inogona kuva iyo inoparadzanisa. Nhengo dzemasero dzinouya kubva kumasero emadziro asi haisi vakuru vakuru masero.

Ectopic Bone Formation Pamusana pepaupine Surgery

Scott, et. al, vanoti kusvika kusvika kune 10 muzana yevarwere vanoita chirwere chisingaoneki - uye kuvhiya shure kunowira muboka iri - kuchakudziridza ectopic bone formation.

Muchipfuva, izwi rokuti "ectopic bone formation" dzimwe nguva rinoshandiswa kurondedzera zvisingadiwi mapfupa emapfupa anowanikwa mumugero wepasipinal . Muna 2002, FDA yakabvumira mapuroteni emapfupa akagadzirwa neMedtronic anonzi Infuse kuti ashandiswe mukuvhiyiwa kwepine. Nzira yekushandisa inotsanangurwa neCDA yaiva yakanyatsotsanangurwa: Sefupa rakabatanidzwa rimwechete Anterior Lumbar Interbody Fusion (ALIF) mukati meLumbar Tapered Fusion Device system (LT-Cage.) Whew!

Asi mushure mokunge agamuchirwa, vanachiremba vazhinji vakatanga kuvashandisa mashoko "off-label," izvo zvinoreva kune zvimwe zvinopfuura izvo zvakagamuchirwa neDFA. Off-label inoshandiswa inosanganisira chirwere chepervical spine chakaita kuti "zviitiko zvinotambudza," kana kuti AE zvive zvichitaurirwa FDA. Ectopic bone formation yaiva imwe yeAE, asi urongwa hwaisanganisira zvimwe zvinhu zvakakomba zvakadai searchnoiditis, kuwedzera kwehutachiona hwehutano, kukanganisa kuwedzera, kenza uye nezvimwe. Kwete!

Medtronic Controversy

Mharidzo yeMilwaukee Journal Sentinal Watchdog Report, iyo yakatevera nyaya iyi kubva muna 2011 (uye inoenderera mberi kuita kudaro), inotaura kuti mukati memavhiki ekutanga kwechirongwa chekliniki yeInfuse, ectopic bone yakawanikwa yakawanikwa mu70% yevadzidzi vacho. Vamwe vevarwere ivavo vaida rimwe kana kuti mamwe mavhivhi kuti varuramise bone risingadiwi uye / kana zvinetso zvezvehutano zvakabva pairi.

Mukuongorora kwake kwehuchapupu hwakabudiswa muna 2013 chirwere cheUvhiya Neurology International , Epstein yakaenzanisa mhizha 13 yakabudisa zvidzidzo kune zvimwe zvidzidzo zvakazobudiswa mumagazini, pamwe chete nemabhuku eDFA uye ruzivo rwakanga ruri mune databases. Anoshuma achiwana "kutanga kwezvakaitika zvisingawaniki uye zvisingaenderani mukati" neIndudzi dzedzidzo.

Anotaura zvakare kuti 40% yezviitiko zvakashata zvakagadzirwa neA ALIF ("off-label" chirwere chetsitsi chakanga chaitwa,) achiwedzera kuti zvimwe zvezviitiko izvi zvaiisa upenyu pangozi.

Zvichakadai, iyo Milwaukee Journal Yakatinel inoshuma kuti Medtronic kana iri pasi-yakataurwa kana kuti haina kumbobvira ichitaura izvi zvinokanganisa kuDFA mumushumo we2004 wakanyorwa naMedtronic-vanobhadhara vanachiremba. MJS inoti "vanachiremba vakanyora pepa ra2004 vaizoenderera mberi kugamuchira mamiriyoni emadhora muzvigaro nemamwe mari kubva kuMedtronic."

Muna Mbudzi wegore ra2014, MJS yakatevera nyaya iyi nedzimwe nyaya ichiti Medtronic yakabvumirana kubhadhara $ 22 mamiriyoni kuti agadzirise zvikwereti 1000 zvinopesana neInfisheni yavo.

Nyaya yacho yakataurawo kuti Medtronic iri kuisa kune imwe $ 140 kuti ivhare "izvo zvinotarisirwa kudaidzwa."

Sources:

Boston Children's Hospital. Chii chinonzi Progenitor Cells? Vhesi dzeStem Stem 101 peji. Boston Children's Hospital website. Yakasvika muna 2015.

Epstein, N. Matambudziko nekuda kwekushandisa BMP / INFUSE mukuvhiyiwa kwepfungwa: Uchapupu hunoramba huchiwedzera. Surgery Neurol Int. 2013: Yakasvika muna Dec 2015.

Fauber, J., Infuse inotsanangurwa mumapfupa ane chirwere chinorwadza. Migumisiro Yechiri. Mutori WepaItinel Watchdog Report. Nyaya Interactive. June 2011.

Fauber, J. Medtronic kubhadhara $ 22 mamiriyoni kuti agadzirise zvido zvepamutemo pamusoro pe spie product. Mharidzo Dhepfenyuro. Milwaukee Wisconsin Journal Sentinel. May 6, 2014.

Scott, M., A., Levi, B., ASkarinam, A., Nguyen, A., Rackohn, T., Ting, K., Soo, C., Muchidimbu Kuongorora Maenzaniso Ectopic Bone Formation. Tsitsi dzeSt. Dev. 2012 Mar 20; 21 (5): 655-667.